A stability indicating UPLC method development and validation for the simultaneous estimation of nateglinide and metformin hydrochloride in bulk and tablet dosage form

Abstract

A stability indicating UPLC method was developed and validated for the determination of Teneligliptin hydrobromide and Metformin hydrochloride in bulk and tablet dosage form. The method was carried out using Endoversil column (2.1 × 50 mm, 1.8 ?m) with mobile phase consisting of 0.1% v/v ortho-phosphoric acid: acetonitrile (80: 20) under isocratic mode with an injection volume 1 μl and at flow rate 0.3 ml/min and both the analytes were monitored at 221 nm. Stress conditions were performed by subjecting the individual analytes to the hydrolysis (acidic, basic), oxidation photolytic and thermal stress conditions. The retention times of Metformin hydrochloride and Teneligliptin hydrobromide were 0.443 and 0.694 min, respectively and showed a good linearity in the concentration range of 250 - 1250 μg/ml for Metformin hydrochloride and 10 - 50 μg/ml for Teneligliptin hydrobromide with a correlation coefficient of 0.9993 and 0.9990. The percentage recoveries of Metformin and Teneligliptin in the marketed dosage form found to be 99.86 and 99.96 respectively. The analytical performance of the proposed method was validated for specificity, linearity, accuracy, precision and robustness, detection and quantitation limits. This method can be used for the routine estimation of these drugs in combined pharmaceutical dosage form.